Posted by Fiona Cole on May 2, 2011
The U.S. Food and Drug Administration (FDA) recently released a warning that Topamax, an anticonvulsant medication, significantly increases the risks of cleft palate birth defects when taken by pregnant women. The FDA warning states that women who are on Topamax during pregnancy have 20 times the risk of giving birth to an infant with an oral cleft.
Topamax is taken as an anti-seizure drug by people who suffer from seizure disorders such as epilepsy. The medication also is used to treat migraines. Topamax, which is also known by its generic name Topiramate, is manufactured by Ortho-McNeil Neurologics. Since January 2007, the FDA estimates that approximately 32 million prescriptions of Topiramate and Topamax have been given out to patients.
Oral cleft birth defects caused by taking Topamax usually develop in the early weeks of pregnancy. It is during this time that women often do not yet know they are pregnant and they continue to take medication. The FDA is now recommending that any woman of child-bearing age who is prescribed Topamax should simultaneously be put on a birth control regimen.
A study carried out by the American Academy of Family Physicians is the driving force behind these new FDA warnings. The American Headache Society has also put out warnings about the use of Topamax for pregnant women and women of a child-bearing age. The American Headache Society has also found a possible link to suggest that Topamax can hamper the effectiveness of certain contraceptives.
“The benefits and risks of Topiramate should be carefully weighed when prescribing this drug to women of child-bearing age,” Jennifer Shepherd of the FDA said. “Alternative medications have a lower risk of oral clefts and other adverse birth outcomes and should be considered for these patients.”
The good news is that cleft palate birth defects are treatable by surgery. But, as the old saying goes, prevention is better than cure. Be sure to discuss all of the risks and benefits of taking Topamax if you are of a child-bearing age.